Political Quotes

“I will speak about two amendments that we will vote on later. Amendment No. 2111 First is the Bingaman amendment. I urge my colleagues to oppose it. It ignores fundamental economic realities of pharmaceutical patent litigation, and it would ultimately result in fewer generic drugs being brought to market and delays in the launch of many of the generic drugs that do go to market. Under current law, a generic drug company that is the first to file an abbreviated new drug application for an existing patented drug is entitled to 180 days of market exclusivity once the generic drug is approved. In other words, they have the exclusive market on it for half a year. This creates a powerful incentive for drug companies to bring generic drugs to market. The present amendment would dilute this right of 180 days of exclusivity and potentially require the exclusivity period to be shared with another drug company's product. Under the amendment, the only way a generic drug company that files the first ANDA could be assured of getting 180 days of market exclusivity is by litigating a challenge to the validity of the branded drug's patent all the way to a final judgment. This is not a sound approach. First of all, patent litigation is very expensive. Full litigation of a drug patent suit typically costs between $3 million and $5 million. Second, most drug patents are ultimately found by the courts to be not invalid; that is, most validity challenges to these patents fail.…”